What will you be empowered to do?
Therapeutics - Therapeutics Development
Associate / Sr. Associate Bioanalytical Scientist
South San Francisco, California, United States
23andMe, the leading consumer genetics and research company, has accumulated a wealth of genotypic and phenotypic information from participants committed to improving human health through advances in genomics. Our Therapeutics team in South San Francisco leverages this data to discover and develop new treatments that can offer significant benefits for patients with serious, unmet medical needs.
This dedicated research and drug development group identifies novel targets using 23andMe's genetic database and performs preclinical research to advance programs towards clinical development. We currently have programs across several therapeutic areas, including but not limited to oncology, respiratory, and cardiovascular diseases. More information about our Therapeutics team is available at https://therapeutics.23andme.com/.
23andMe Therapeutics is seeking an outstanding Bioanalytical Scientist to join a collaborative, cross-functional Therapeutics Development organization focused on bringing genetically-validated therapeutics to patients with high unmet needs.
Determining the concentration of a drug and other analytes in a subject or a patient after dosing is central to understanding how our therapeutics work and what levels may be safe and/or efficacious. Our Bioanalytics function has a critical role in advancing our drug development programs and is responsible for conceptualizing and implementing bioanalytical strategies across our pipeline. This is a unique opportunity for an early career drug developer to join a growing team of development scientists and drive our bioanalytics capabilities and drug development efforts.
The candidate will be responsible for performing laboratory activities in support of PK, PD/PK, and immunogenicity assessments for preclinical/clinical drug discovery and development programs. These activities will include designing assays, performing method development, troubleshooting, qualification, and execution, generating data, documenting the methods and data, and collaborating with internal and external partners. As a member of a matrix organization, the candidate will work closely with pharmacokinetic scientists, toxicologists, biologists, antibody engineers, in vivo pharmacologists, and clinicians, and regularly participate in cross-functional team meetings. The assays developed by the candidate may be used in preclinical and clinical studies evaluating the PK, safety, and efficacy of investigational therapeutic agents. The candidate may author bioanalytical reports and summaries used in regulatory filings (eg., INDs). In summary, the candidate will design and implement bioanalytical assays that support the development of new therapeutics to treat human diseases.
What You’ll Do
- Develop, qualify/validate, and implement high quality ligand binding assays (ELISA, MSD, Gyros platforms) for the quantitation of large molecule therapeutics
- Design bioanalytical methods, including the identification and preparation of critical reagents and selection of assay format
- Assess the immunogenicity of large molecule therapeutics by developing, qualifying/validating, and implementing high quality ligand binding assays (ELISA, MSD, Gyros platforms)
- Develop and implement the bioanalytical strategy for drug development programs advancing from preclinical studies to IND-enabling studies and clinical studies
- Independently design studies, generate data, author draft reports summarizing laboratory results , and prepare study summaries for presentations
- Serve as a bioanalytical subject matter expert on internal and external cross-functional teams, and present data and strategies when necessary
- Oversee the development, transfer, and qualification/validation of bioanalytical assays at external partners and/or collaborators
- Maintain accurate notebooks and real-time experiment documentation
- Additional responsibilities will include assay troubleshooting and development of new technology platforms to support the growing pipeline
- Maintain compliance with all internal SOPs and regulatory requirements at all times
What You’ll Bring
- BS with five years, MS with three years,, or Ph.D. and up to two years of experience in biology, biochemistry, analytical sciences, assay development, or relevant categories.
- Exceptional wet-lab technical skill (pipetting, sample processing) and direct experience in developing assays and techniques used for the detection of analytes in complex biological matrices
- Demonstrated ability to work efficiently and collaboratively in a cross-functional team environment
- Demonstration of initiative, teamwork, collaboration, and technical expertise as an independent and creative scientist
- Outstanding written and verbal communication skills
- Excellent record keeping
- Enthusiasm for drug development, assay development, and/or preclinical and clinical research
- Hands-on laboratory experience with large molecules
- Hands-on experience applying a broad range of bioanalytical technologies used for ligand binding assays (MSD, Gyrolab, ELISA, etc.) and the detection of large molecules in complex biological matrices
- Hands on experience with immunogenicity assay development
- Prior pharma industry experience with biologics, preferably in an immunoassay development
- Relevant laboratory GxP experience
- Experience with external collaborations and oversight of external contracts
- Working knowledge of regulatory bioanalytical method validation guidance
23andMe, headquartered in Sunnyvale, CA, is a leading consumer genetics and research company. Founded in 2006, the company’s mission is to help people access, understand, and benefit from the human genome. 23andMe has pioneered direct access to genetic information as the only company with multiple FDA authorizations for genetic health risk reports. The company has created the world’s largest crowdsourced platform for genetic research, with 80 percent of its customers electing to participate. The platform also powers the 23andMe Therapeutics group, currently pursuing drug discovery programs rooted in human genetics across a spectrum of disease areas, including oncology, respiratory, and cardiovascular diseases, in addition to other therapeutic areas. More information is available at www.23andMe.com.
At 23andMe, we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at firstname.lastname@example.org. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.
Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.
San Francisco Bay Area Base Pay Range
Senior Associate Scientist: